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vigilance is required with patients using CS1T, even though studies demonstrate thai with adequate education and involvement of the patient there is no increased incidence of DKA with pumps. Because pumps use only short-acting forms of insulin, if delivery is interrupted there is no safety net of intermediate- or long-lasting insulin to prevent the breakdown of fat and muscle to prevent the conversion of these substrates into ketone bodies (22,23). If a patient has nausea or vomiting or any other symptoms related to DKA, an immediate check of blood sugars and ketones is warranted. If the patient is unable to drink liquids and replenish fluids, a physician should be called immediately and the patient must go to the hospital for administration of intravenous insulin, replacement of lost fluids and electrolytes, and treatment of the underlying cause of inadequate insulin, If ketones are positive but the patient is able to take liquids orally, then aggressive fluid ingestion is begun and insulin is administered on a schedule determined by the physician and guided by frequent (hourly) self-monitoring of blood glucose levels and recurrent evaluation of the degree of ketosis present or its resolution. Until the ketosis clears, additional insulin is best initiated by syringe injection with a routine change of infusion site and by troubleshooting the pump, insulin, and delivery system prior to resuming pump therapy. As in all cases of ketoacidosis, the cause needs to be determined and corrected to avoid its recurrence.

The other acute event of insulin therapy is hypoglycemia, and its prevention or limitation is of utmost importance in the prevention of premature mortality (24) and the achievement of euglyceniia. Jn type I diabetes patients, the adequacy of prevention of hypoglycemia is based on detection, which in turn is dependent on the frequency and regularity of self-monitoring of blood glucoses. Patients on insulin should monitor blood sugar levels four to six times daily and be familiar with the actions necessary to treat an acute event and prevent future episodes.

When hypoglycemia occurs, the most appropriate treatment is to ingest known quantities of glucose to effect a predictable rise in serum glucose levels. The DCCT based the guidelines for treatment on the knowledge that 15 g of glucose will raise blood sugars 15 mg/dl in 15 minutes. If the current level is 40 mg/dl and the target is 100 mg/dl. then 60 g of glucose will achieve that. Patients often overtreat hypoglycemia by taking copious amounts of glucose, for example, in the form of candies or juices, resulting in an exaggerated rise in blood sugars to hyperglycemic ranges.

The occurrence of hypoglycemia is greatest during die overnight or sleep period, when 60% of hypoglycemic events occur (25). Maintaining bedtime and 3 a.m. glucose levels at at least 100 mg/dl diminishes this event rate. Similarly, minimum glucose levels of 100 mg/dl are preferable before engaging in activities such as driving, exercise, drinking, or others that might result in an increased risk or consequence from hypoglycemia. Blood sugars should be checked at the beginning of any such activity that can cause wide swings in plasma glucose and

periodically (every hour or two hours) during the activity, to detect and prevent severe hypoglycemia. The knowledge accumulated from monitoring blood glucose levels and their changes should be used as the basis for changing the basal dose of insulin delivered during similar activities in the future. These rates modified for activities, known as temporary basal rates, may vary in size and duration according to the level of activity and its time of occurrence. As with all insulinadministration regimens, these are decided on an individual basis and may need to be adjusted as the patient and health-care team deem appropriate. Before, during, or after any activity that can lower blood glucose, bolus dosages should be reduced to prevent hypoglycemia and then glucose should be measured to determine the correct reduction for future boluses at these times.

For patients with hypoglycemic unawareness, targets appropriate for this condition need to be set. The occurrence of frequent hypoglycemic events (more than three per month) is known to result in a decrease in the catecholamine response to hypoglycemia and a decrease in awareness of these events (26).

The frequency of hypoglycemic unawareness is much greater than previously thought. Only now is it being documented and recognized in studies utilizing systems (hat continuously monitor interstitial blood glucoses and accumulate these data for later interpretation. Use of this technology prompts adjustment of basal and bolus rates that consistently address the issue of patient under-bolusing at meals and over-basaling at other times. Appropriate targets for patients with hypoglycemic unawareness are 130 mg/dl before meals, bed, and driving, and at 3 a.m. Prevention of hypoglycemia in these patients results in partial correction of hypoglycemic awareness and is one of the goals of and reasons for initiating insulin-pump therapy. Generally the family or other care-givers of the patient with diabetes should be instructed in the recognition of hypoglycemia and the appropriate administration of glucose and/or glucagon if necessary. Patients should wear or carry medical identification bracelets or cards indicating that they have diabetes so hypoglycemia can be recognized and treated. All patients using pump therapy can minimize their exposure to unwanted insulin by setting the auto-off safety alarm so that if they don't actively do something with their pump to tell it that they are alert it will automatically stop delivering insulin at a patient-determined time and prevent hypoglycemia from being prolonged by continued delivery of insulin. Lastly, no insulin pump is waterproof. Putting the pump in water has resulted in hypoglycemia in patients who thought otherwise and unexpectedly received an overdelivery of insulin.

PEDIATRIC PATIENTS

If the growth in insulin-pump use among adult type 1 diabetes patients has been extraordinary, it has been explosive among pediatric patients with type 1 diabetes. In 1997 the number of young people using pump therapy was less than 500, but

by 1999 that number had grown to more than 5000. The reason for this is the realization by the general population of pediatric type 1 patients and their physicians that insulin-pump therapy offers an alternative with more choices and less restriction of behavior and activity than with syringes while also achieving an improved blood sugar environment and an associated lowering of hypoglycemia event rates (27-32). In the study authored by White et al., the rate of severe hypoglycemia in children age 2-16 years in one review was approximately 60 per 100 patient-years whether undergoing usual (two injections per day) or intensive-care regimens; CSH lowered this rate to less than 10 both in and outside the study group. Another study found that the only characteristic predictive of failure to achieve metabolic control with pumps is the fear of needles. Children or adolescents may simply want a pump; have busy, changing schedules; seek more flexibility in activities; or have nocturnal hypoglycemia or many wide swings in their blood sugars with conventional treatment. It is necessary that the child being considered be either performing or willing to perform three or four self-monitored blood glucose measurements per day. Obviously either the patient—or his family, in the case of a very young patient—should be interested in pump therapy and must be reliable. "Reliable" can be defined simply as coming in for follow-up visits.

Starting Dosages for Pediatric Patients

Guidelines for initial starting dosages in children are different from those for adults (Table 3). It is usual to start with the total daily dose for injection therapy and divide it into two parts—basal and bolus—rather than reducing the total dosage by 20% as is done in adults. The basal amount is 50% of the total prepump dosage and is administered as a single rate for the entire 24-hour period. The other 50% is given in evenly divided amounts constituting the boluses for each meal. Insulin needs vary as aging and growth occur. In prepubertal children, the highest basal rate (sometimes as much as twice the normal basal) is usually required between 9 p.m. and 12 a.m. The lowest rate in this age group is often between 3 a.m. and 7 a.m. As a child enters puberty, the most frequent scenario is for the highest basal rates to be between 3 a.m. and 9 a.m. and between 9 p.m. and 12 a.m. (33). As with adults, it is simplest and best to begin pump therapy

with a single basal rate and make changes as indicated by information obtained from SMBG or continuous glucose monitoring. The basic rule of medicine— "Keep it simple"—is applicable to determining bolus requirements. Meal requirements are determined by calculating carbohydrate requirements. The two methods of doing this are to count either grams or servings of carbohydrates. The clinician should devise a meal plan with foods that the child will actually be eating, not an idealized, unrealistic diet program, [f neither grams nor servings of carbohydrates can be quantified, patients and their families can be instructed to give appropriate boluses for low-, medium-, and high-carbohydrate meals or foods. The easiest method is to start with a preset amount of carbohydrate at each meal and then determine the amount of insulin required to balance the meal's carbohydrate load. The ratio will frequently vary according to the time of day. If bolus administration is not feasible, an increase in basal rates can minimize blood glucose elevation after snacks or meals. Both the patient and the family should have correction doses written down for them, and, depending on the patient's age and type of insulin, it may be necessary to amend the rule of 1500 to match individual needs and insulin sensitivities.

Preventing DKA and Treatment of Hyperglycemia in Pediatric Patients

Patients and families should always have available an alternative to pump therapy. This means that pens and/or needles need to be mastered and used when necessary. If the patient has any symptoms of DKA, including but not limited to nausea or abdominal pain, the blood sugar should be checked. If it is above 200 mg/dl and ketones are present in the urine or blood, a correction bolus should be administered by Injection and the infusion site should be changed. The pump should be scrutinized for problems (low battery, no insulin, etc.), and these need to be corrected. The blood sugar should be rechecked in 1 hour; if it is not lower or if nausea is present, the health-care team needs to be contacted immediately. If the blood sugar is greater that 200 mg/dl but no ketones or symptoms of DKA are present, the correction bolus can be administered by pump. The blood sugar should be rechecked in an hour. If it is falling, the pump need not be removed. If the blood sugar is not coming down, the patient needs to take the correction bolus by injection and the site must be changed.

In the morning, the blood sugar should be checked at least 1 hour prior to setting off for school. This is enough time so that, as recommended by the Yale Pediatric Pump Program, if the blood sugar is greater than 250 mg/dl the patient will be able to change the site before leaving for school. If the blood sugar is greater than 200 mg/dl while at school, the patient should take a bolus via pump and recheck the blood sugar an hour later. If the blood sugar is not corning down, the child should take the appropriate, predetermined correction bolus by pen or i a -5,

needle and the site can be changed when the child returns home. One of the most common causes of hyperglycemia in this age bracket is the omission of food boluses; this is easily prevented through education.

Hypoglycemia Prevention iri Pediatric Patients

The key to prevention of hypoglycemia is frequent measurements of blood sugar, enabling detection and correction. Often hypoglycemia in children is not associated with classic hypoglycemic symptoms, as documented by studies using continuous glucose measurements (34-36). All these studies highlighted the importance of obtaining 3 a.m. blood sugar measurements intermittently because of the prolonged asymptomatic occurrences of nocturnal hypoglycemia, if the patient has hypoglycemic unawareness, then a review and adjustment of the targets for glycemic control may be needed. Hypoglycemia is frequently due to over-bolusing. Some pumps come with software that allows for downloading and examination of the frequency and amount of boluses. This tool is extremely useful in detecting and correcting errors.

GETTING STARTED

Pump therapy should not be made unnecessarily complicated for the patient or the family. In most centers, the patient's use of CSIF begins after the insulin pump has been delivered, with a visit to the home by the pump trainer. The trainer reviews the features of the pump and techniques for insertion and care of the site. Later, the trainer provides the physician with a checklist of all the activities taught, understood, and mastered.

On the morning of the first visit to the office or clinic for the purpose of starting the pump, the patient, family member, or trainer inserts the infusion set. The decision as to who does the insertion is up to the patient; children should never be forced to do it themselves. Selection of the site is somewhat age-dependent because of the amount of subcutaneous tissue in various anatomical locations. Older children do well with the microinfusion set in the hip area, but many children under 6 are vei^ slender and as a result do best with a silhouette infusion set in the buttocks. To minimize discomfort, "toeing in" is recommended, as is the use of products such as xylocaine spray or EMLA. -g

The patient has taken insulin the evening before die first session and begins |

that morning with insulin in the pump. That initial visit includes education about |

the choice of insulin to be given as boluses and when blood sugars should be checked (before meals and at 3 p.m., bedtime, 12 a.m., and 3 a.m.). Basic instruc- ?

(ions are provided on how to suspend the delivery of insulin by the pump, how a to disconnect, and how to avoid problems, and numbers to call for help and J

assistance are given. The next day the patient or a family member calls the center a s

■a and reports the blood sugar levels, actions taken, and food eaten; in response to these, the nurse explains any changes that are needed. Patients are encouraged to call if they encounter problems or have concerns. On day 3, in another session at the office or clinic, the patient or caregiver fills the reservoir with insulin, attaches the tubing, and demonstrates the ability to insert Lhe infusion set. Whoever is responsible needs to show during this visit how he or she changes basal rates and suspends the pump. Adjustments in basal rates, coirection doses, and boluses based on redetermining the carbohydrate sensitivity are made during this session. The need to disconnect for exercise is emphasized, and, as in all sessions, questions are encouraged and answered. If the pump has the remote feature, it is taught at either the first visit or this one. For the next 6 weeks, the patient continues to monitor blood sugars and report levels that are out of range; any other problems are dealt with over the phone. A routine follow-up visit is scheduled at 6 weeks poststan to obtain an HbA,c level, to instruct in the advanced features of the pump, to troubleshoot, and to assess competence and comfort with the pump and its use.

PREGNANCY

Pregnancy offers the clinician the unique opportunity to reap immediate rewards for good glucose control. In a science in which adverse long-term events frequently take 15 years to occur, normoglycemia during pregnancy and preconception results in healthy pregnancies and reduced complications for both the mother and the child. The targets for blood glucose are constant during preconception and pregnancy. Fasting blood sugars should be in the range of 60-90 mg/dl. This is the same level that should be aimed for in the overnight, 3 a.m., and preprandial periods. One-hour postprandial blood sugars should be 120-140 mg/ dl (38-40). The challenge of adhering to this is made somewhat easier by the use of insulin pumps.

In terms of insulin sensitivity, pregnancy can be divided into four distinct periods of lime determined by the gestational age and the resulting milieu for glucose production, uptake, and utilization. This progressive, diminished insulin sensitivity is caused in large part by the hormones being produced to maintain the pregnancy as it progresses. Weeks 6-18 require the least insulin, estimated at 0.7 U/kg current body weight. The requirement from 18 to 26 weeks' gestation rises, on average, to 0.8 U/kg current body weight and then to 0.9 U/kg for weeks 26-36. In the final stage of pregnancy—week 36 till delivery—the estimated total insulin daily requirement is 1.0 U/kg (41). As with all dosage guidelines, individual determinations on a patient-by-patient basis must be done because requirements can vary widely.

Special considerations during pregnancy include the avoidance of diabetic ketoacidosis, which can have a fetal death rate as great as 50% (42). Emphasis is on early detection: frequent monitoring of blood sugars to detect an increase in these values at the earliest signal of diminished insulin delivery, prompt action by giving correction bolus by injection for any blood sugar greater than 160 mg/ dl if the glucose does not respond to one given by pump, and conscientiously checking urine for ketones every morning and whenever the blood sugar is higher than target. In our practice, use of a combination of long-lasiing insulin given by injection at bedtime together with pump therapy has prevented any events of nocturnal DKA.

The sites used for the infusion set are different than in the nonpregnant state only in the last trimester and during the actual delivery. The abdomen is to be avoided because of the stretching and the increased risk of cellulitis. This also prevents having to remove the pump during delivery in the event of a caesarian section. The infusion rate during delivery may need to be reduced dramatically and can even be put on suspend. Although not specifically approved for use either in pumps or during pregnancy, the fast-acting insulin analogs are commonly used.

Insulin pumps enable meeting the challenges presented by pregnancy, which may include dramatic decreases in food intake because of morning sick-

ness as well as demands for rigid control while limiting hypoglycemia and its adverse effects. The most important part of intensive therapy during pregnancy is the frequent monitoring of blood sugars—usually before and after meals, at bedtime, and periodically during the middle of the night. It is essential to thus continuously verify the appropriate basal and bolus amounts as the pregnancy proceeds. There is no contraindication for starting insulin pumps during pregnancy, and no special risks.

SPECIAL CONSIDERATIONS Hypoglycemic Unawareness

Even the nonintensively controlled group in the DCCT was not spared hypoglycemic events. In patients wiLh impaired awareness, the number of events has been estimated at 160 per year (43,44). This rate is six times that in people with type I diabetes with unimpaired awareness. Analysis of meter downloads demonstrated that even at HbA,c levels of 8.5%, 12% of all readings were below the targets set by the DCCT. When euglycemia is attempted, iatrogenic hypoglycemia is common, especially compared with thai reported hy standard blood glucose measurement. Analysis of continuous glucose monitoring revealed that 87% of all subjects had hypoglycemic events and 62% had nocturnal hypoglycemia that was not accompanied by symptoms and therefore would be unrecognized. For an average of 2.4 hours per day, blood sugar levels were in the the range considered hypoglycemic; there were 1.8 distinct hypoglycemic episodes per 24 hours, and each of these episodes lasted an average of 72 minutes. It is known that brain metabolism is severely impaired at blood glucose levels under 55 mg/dl; this is linked to the decrease in counterregulatory hormone release. Diabetes of longer duration typically results in repetitive hypoglycemia and unawareness. In these patients, careful avoidance of low blood sugars can result in partial restoration of awareness, indicating that targets for glucose should be set higher with the goal being to prevent low blood sugars. The recommended preprandial, bedtime, and overnight targets in this population are 100—160 mg/dl, and postprandial targets should be approximately 50 mg/dl higher than the preprandial targets (45).

fact that there is no long-lasting insulin in the patient is a tremendous benefit in terms of prevention of unexpected hypoglycemia and its adverse results.

Maintenance of long-term euglycemia is achievable in most, if not all, patients with diabetes. Intensive therapy should achieve two goals: the lowering of blood sugars to levels that have a positive impact on microvascular complications of diabetes and the avoidance of hypoglycemia and its short- and long-term damaging effects. Both of these goals need to be accomplished while allowing the patient to enjoy a normal lifestyle. These targets are attainable only if insulin is delivered in a physiological way. This means inclusion of the patient in the decision-making process of determining insulin requirements based on current glucose levels and expected insulin need for meals and activity. It is the patient's knowledge of glucose levels and their response to administered insulin that makes all this possible. The most physiological mode of delivering insulin is by use of insulin pumps. Patients must be willing to take part in the glucose testing and the quantification of insulin needs for the multiple events that make a day eventful in terms of glucose excursions and insulin requirements. Pumps are a way to "decriminalize" diabetes and allow people with this disease to once again actively participate in the many aspects of a normal life.

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Good Carb Diet

Good Carb Diet

WHAT IT IS A three-phase plan that has been likened to the low-carbohydrate Atkins program because during the first two weeks, South Beach eliminates most carbs, including bread, pasta, potatoes, fruit and most dairy products. In PHASE 2, healthy carbs, including most fruits, whole grains and dairy products are gradually reintroduced, but processed carbs such as bagels, cookies, cornflakes, regular pasta and rice cakes remain on the list of foods to avoid or eat rarely.

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